The EPO Enlarged Board of Appeal has issued its decision in case G1/07 (surgical methods).

The Board had been asked to consider whether the inclusion of any physical intervention in a claimed method led that method to be excluded from patentability, regardless of whether the step was not per se aimed at maintaining life and health. In their decision, the EBA stopped short of saying that 'surgery' must involve therapy for the exclusion to apply.  

The Board further confirmed that multi-step methods are not patentable if they include a single step that falls within the exclusion. However the Board set out a new, narrower approach to the meaning of “treatment by surgery”. 

Under European law, methods for the treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body, are excluded from patentability.

The extent of this exclusion, as regards methods of treatment by surgery, had previously been subject to differing interpretations at the EPO. Some Technical Boards of Appeal considered that inclusion of any intervention which could be considered surgical would be enough for a claimed method to fall within the exclusion, whereas others considered the purpose of the method to be decisive.

The application in question in G1/07 relates to a patent application from Medi‑Physics, Inc. which concerns a method of imaging and evaluating blood flow involving the delivery of polarized ¹²⁹Xe to the body.  The method is primarily diagnostic, but does not fall under the exclusion for diagnostic methods. 

The following three questions were referred to the Enlarged Board of Appeal, to enable determination of whether the claimed methods were excluded from patentability at the EPO:

1. Is a claimed imaging method for a diagnostic purpose, which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a "method for treatment of the human or animal body by surgery" if such a step does not per se aim at maintaining health and life?

2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

3. Is a claimed imaging method for a diagnostic purpose to be considered as being a constitutive step of "method for treatment of the human or animal body by surgery" if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

The legal principle behind the exclusion of therapeutic and diagnostic methods from patentability is to free medical and veterinary practitioners from being potentially hampered by patents in the application of the best possible treatment on their patients.  The Board considered that to give full effect to this purpose it was necessary to exclude from patentability multi-step methods which comprise or encompass a surgical step and to define methods for treatment by surgery by their nature (surgical or non-surgical treatment) rather than their purpose (therapeutic or non-therapeutic).

In answering question 1, the Enlarged Board therefore stated that "treatment by surgery is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose."

However the Board also held that the definition of treatment by surgery used in some earlier cases was too broad and un-satisfactory in the context of “today’s technical reality”, where some invasive techniques are routine and safe. The Board matched the purpose of the exclusion with the meaning to be given to “treatment by surgery”, being “physical interventions on the body which require professional medical skills to be carried out and which involve health risks even when carried out with the required medical professional care and expertise”. This may leave open the possibility that minor procedures, not involving substantial health risks, could fall outside the exclusion after all.

The Enlarged Board also confirmed, in answer to question 2, that any claim encompassing a step which is a "method of treatment of the human or animal body by surgery" is not allowable as it stands. The exclusion from patentability can potentially be avoided by disclaiming or omitting the surgical step from the claims.  The overall patentability of such claims will depend, on a case by case basis, on whether other requirements of the EPC can be met, including clarity, sufficiency and the requirements for the allowance of a disclaimer.

Finally, in response to question 3, the Board stated that a claimed imaging method would not be considered as a "method of treatment of the human or animal body by surgery" merely because the data obtained from that method allowed a surgeon to decide on the course of a surgical treatment.

It should be noted that the Enlarged Board in this case emphasised that their specific conclusions were limited to the facts of the case in question. It remains to be seen how first instance departments of the EPO will interpret the Board’s ruling.

Overall, however, the implication of this decision is that any surgical method will be excluded from patentability, regardless of whether it has the goal of maintaining, restoring or improving health.

Published on 15th February 2010